| Primary Device ID | 07321820063444 |
| NIH Device Record Key | 3351bc1b-4f4d-4ddc-b7ec-adc4525a84f9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vivo 50, VIvo 65 |
| Version Model Number | 006344 |
| Catalog Number | 006344 |
| Company DUNS | 357007657 |
| Company Name | Breas Medical AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com | |
| Phone | 855-436-8724 |
| supportUS@breas.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07321820063444 [Primary] |
| CBK | Ventilator, Continuous, Facility Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-18 |
| 07321820063444 | Protective Cover (replaces 004938) |
| 07321820051892 | Click-on battery charger- US |
| 07321820051007 | Vivo 50/65 PC Software |
| 07321820050666 | Polishing Cloth |
| 07321820049394 | Carry bag |
| 07321820046683 | Patient Air Inlet filter (white, disposable), 10 pcs |
| 07321820046676 | Patient Air Inlet filter (grey, washable), 5 pcs |
| 07321820048991 | External battery cable 24V DC |
| 07321820048861 | USB Cable A-B |
| 07321820045594 | Click-On Battery |